Hartalega NGC Sdn. Bhd.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Hartalega NGC Sdn. Bhd.” (first 2014, latest 2026), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 103 days. Since 2017 the median was 106 days, against 118 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 2 | 104 |
| 2015 | 5 | 97 |
| 2016 | 1 | 255 |
| 2017 | 4 | 108 |
| 2018 | 0 | — |
| 2019 | 4 | 208 |
| 2020 | 4 | 58 |
| 2021 | 1 | 57 |
| 2022 | 3 | 109 |
| 2023 | 1 | 184 |
| 2024 | 0 | — |
| 2025 | 3 | 92 |
| 2026 | 3 | 159 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hartalega NGC Sdn. Bhd. took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | 24 | 24 |
| KGO | Surgeon'S Gloves | 5 | 5 |
| LYY | Latex Patient Examination Glove | 1 | 1 |
| OPC | Powder-Free Polychloroprene Patient Examination Glove | 1 | 1 |
Review panels
- General Hospital (31)
Most recent Hartalega NGC Sdn. Bhd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260558 | Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate; Latex Powder Free Surgical Gloves with Colloidal Oatmeal Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | KGO | 2026-07-28 | 159 |
| K254285 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Dark Violet Blue | LZA | 2026-07-20 | 201 |
| K260867 | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black) | LZA | 2026-06-17 | 92 |
| K250861 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) | LZA | 2025-10-23 | 216 |
| K251319 | Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) Extended Cuff | LZA | 2025-07-30 | 92 |
| K243818 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) | LZA | 2025-01-08 | 27 |
| K223437 | Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) | LZA | 2023-05-17 | 184 |
| K222225 | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) | LZA | 2022-11-11 | 109 |
| K221718 | Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) | KGO | 2022-09-24 | 103 |
| K214074 | Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs | KGO | 2022-05-26 | 150 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hartalega NGC Sdn. Bhd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Hartalega Sdn Bhd (61 510(k)s)
- Hartalega Sdb. Bhd. (4 510(k)s)
- Hartalega Snd. Bhd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hartalega NGC Sdn. Bhd.?
FDA lists 31 510(k) clearances under the applicant name “Hartalega NGC Sdn. Bhd.” (first 2014, latest 2026), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Hartalega NGC Sdn. Bhd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hartalega NGC Sdn. Bhd. is 103 days. Since 2017: 106 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Hartalega NGC Sdn. Bhd.?
The most frequent FDA product codes under this applicant name are LZA (Polymer Patient Examination Glove, 24); KGO (Surgeon'S Gloves, 5); LYY (Latex Patient Examination Glove, 1).
Next steps
- See all 31 Hartalega NGC Sdn. Bhd. clearances with predicates and recalls
- Run predicate analysis for product code LZA, Hartalega NGC Sdn. Bhd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.